Introduction

1. Bradburd, Daniel, “Fuzzy Boundaries and Hard Rules: Unfunded Research and the IRB,” American Ethnologist 33 (November 2006): 494. For links to news stories about current debates, see Illuminata, Inc., “News In Research With Human Subjects,” www.illuminata-inc.com/News.html.

2. Halpern, Sydney, “Hybrid Design, Systemic Rigidity: Institutional Dynamics in Human Research Oversight,” Regulation & Governance 2 (2008): 86; Fost, Norman and Levine, Robert J., “The Dysregulation of Human Subjects Research,” JAMA 298(14 November 2007): 2196–98.

3. Advisory Committee on Human Radiation Experiments, Final Report (New York, 1996), 495; Schrag, Zachary M., Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 (Baltimore, 2010), 130–36.

4. Jeffrey Botkin, comments, Secretary’s Advisory Committee on Human Research Protections, Transcript, Sixteenth Meeting, 16 July 2008, 230–33, www.hhs.gov/ohrp/sachrp/ (16 July 2010); Nancy Walton, “The Thalidomide Tragedy,” Research Ethics Blog, 27 April 2010 http://researchethicsblog.com (16 July 2010).

5. Fitzgerald, Maureen H., “Punctuated Equilibrium, Moral Panics, and the Ethics Review Process,” Journal of Academic Ethics 2 (2005): 5.

6. See, for example, Reverby, Susan M., Examining Tuskegee: The Infamous Syphilis Study and Its Legacy (Chapel Hill, 2009); Rothman, David J. and Rothman, Sheila M., The Willowbrook Wars: Bringing the Mentally Disabled into the Community (1984; reprint, New Brunswick, 2005); Galliher, John F., Brekhus, Wayne H., and Keys, David P., Laud Humphreys: Prophet of Homosexuality and Sociology (Madison, 2004); and the various works cited by the articles in this issue.

7. United States Holocaust Memorial Museum, “The Doctors Trial,” www.ushmm.org/research/doctors/ (30 July 2010).

8. Schrag, Ethical Imperialism.

9. Petryna, Adriana, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects (Princeton, 2009); Abadie, Roberto, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects (Durham, 2010).